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Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis — FIBARRIX  

Bronchiolitis Clinical Trial

Official title:
FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"

Clinical Trial Summary

The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.

Clinical Trial Description

This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis.

Patient Registries:

SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca.

Sample size

The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas:

Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0%

The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant.

Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62

Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02458300
Study type Interventional
Source Universidad Católica San Antonio de Murcia
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date March 2015
View Details
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